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510(k) K881879

ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 by Alpha-Tec Systems, Inc. — Product Code JSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1988
Date Received
May 4, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
Review Panel
MI
Submission Type

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  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)
  • K850308 — C.L.A.T. (March 20, 1985)